A Phase 1 interventional study of Nicorette Strongmint lozenge 4 mg and Niquitin MiniMint lozenge 4 mg in Tobacco Dependence, sponsored by McNeil AB. Completed at 1 site in Russian Federation. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-27.
Sponsored by McNeil AB · Phase 1, Interventional, and Other
This is a research study to verify the same effectiveness and safety profile for the test product, Nicorette Strongmint lozenge, as for an already approved product, NiQuitin® Minimint lozenge (reference product), in a standardized mode. This verification is done in a so-called bioequivalence study, which means that the same amount of the same active substance (nicotine), in the same dosage form, for the same route of administration, and meeting the same or comparable standards is performed.
During the study visits, blood samples will be drawn to measure the level of the substance in the blood to verify that the two products are comparable. Tolerability of the treatments will be evaluated based on reported and observed adverse events.
This is a single-dose, two-period crossover, randomized, fasting, open-label, bioequivalence study.
244 male and female volunteers with a smoking history of minimum 3 months and aged between 18 and 45 years, inclusive, and motivated to quit will be included. The treatment administration order will be randomized with an equal number of subjects in each treatment sequence.
Single doses of 4 mg Nicorette Strongmint Lozenge (i.e. test product) and 4 mg NiQuitin® Minimint Lozenge (i.e. reference product) will be administered in a standardized mode, on two separate treatment visits. A washout period of minimum 48 hours will separate the treatment administrations.
An abstinence period of 12 hours including an overnight stay at the clinic is required at both treatment occasions.
Blood for pharmacokinetic analyses will be drawn pre-dose (i.e. within 5 minutes before drug administration) and at 10, 15, 20, 30, 40, 50, and 60 minutes, as well as 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours after start of drug administration. Thus, 17 samples will be collected per treatment visit.
Subjects will be monitored to capture any adverse events that may occur.
Exclusion Criteria:
A single dose of one nicotine 4 mg lozenge will be administrated orally to slowly dissolve in the mouth for nicotine absorption via the buccal mucosa.
Drug: Nicorette Strongmint lozenge 4 mg
A single dose of one nicotine 4mg lozenge will be administrated orally to slowly dissolve in the mouth for nicotine absorption via the buccal mucosa.
Drug: Niquitin MiniMint lozenge 4 mg
A single dose of one Nicorette lozenge 4mg lozenge administrated orally to slowly dissolve in the mouth.
Also known as: Nicorette lozenge 4 mg
A single dose of one Niquitin Minimint lozenge 4mg administrated orally to slowly dissolve in the mouth.
Also known as: Niquitin lozenge 4 mg
Peak Plasma Concentration (Cmax) of nicotine
The maximum observed plasma concentration (Cmax)
Time frame: At baseline, 10, 15, 20, 30, 40, 50 and 60 minutes, 1.25, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours after start of drug administration.
The time at which the maximum nicotine concentration (Cmax) occurs (Tmax)
Tmax is defined as the time point at which the maximum nicotine concentration (Cmax) occurs
Time frame: At baseline, 10, 15, 20, 30, 40, 50 and 60 minutes, 1.25, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours after start of drug administration.
Area under the plasma concentration versus time curve (AUCt) from start of nicotine administration until the last measurable concentration.
AUCt is defines as area under the plasma concentration versus time curves from start of drug administration until the last measureable concentration.
Time frame: At baseline, 10, 15, 20, 30, 40, 50 and 60 minutes, 1.25, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours after start of drug administration.
Area under the plasma concentration versus time curve (AUC∞) of nicotine
AUC∞ is defined as area under the plasma concentration versus time curves from start of drug administration until the nicotine plasma concentration is negligible (infinity).
Time frame: At baseline, 10, 15, 20, 30, 40, 50 and 60 minutes, 1.25, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours after start of drug administration.
The extrapolated part of area under the plasma concentration versus time curve (AUC∞) of nicotine.
The area under the plasma concentration versus time curves from start of drug administration until infinity.
Time frame: Extrapolation from 12 hours after start of drug administration until infinity.
Determination of the terminal elimination rate constant (lambda_z) for nicotine.
The rate at which the drug is removed from the body system.
Time frame: At baseline, 10, 15, 20, 30, 40, 50 and 60 minutes, 1.25, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours after start of drug administration.
The plasma half-life (t1/2) of nicotine.
The time taken for the nicotine plasma concentration to fall to half its original value.
Time frame: At baseline, 10, 15, 20, 30, 40, 50 and 60 minutes, 1.25, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours after start of drug administration.
Percentage of Subjects with Treatment-Emergent Adverse Events after single-dose administration of Nicorette Strongmint Lozenge 4mg or NiQuitin Minimint Lozenge 4mg.
Frequency (%) of subjects experiencing treatment-emergent adverse events by treatment, system organ class and preferred term.
Time frame: From first dose received up to 3.5 weeks + 30 days follow up after study completion for any unresolved adverse events.
Percentage of Subjects with Treatment-Emergent Adverse Events after single-dose administration of Nicorette Strongmint Lozenge 4mg or NiQuitin Minimint Lozenge 4mg - By Worst-Case Severity.
Frequency (%) of subjects experiencing treatment-emergent adverse events by treatment, system organ class, preferred term and severity.
Time frame: From first dose received up to 3.5 weeks + 30 days follow up after study completion for any unresolved adverse events.
Percentage of Subjects with common treatment-emergent adverse events (AEs) after single-dose administration of Nicorette Strongmint Lozenge 4mg or NiQuitin Minimint Lozenge 4mg.
Percentage (%) of subjects with commonly reported treatment-emergent adverse events by system organ class and preferred term.
Time frame: From first dose received up to 3.5 weeks + 30 days follow up after study completion for any unresolved adverse events.
Percentage of Subjects with treatment-related adverse events (AEs) after single-dose administration of Nicorette Strongmint Lozenge 4mg or NiQuitin Minimint Lozenge 4mg.
Percentage (%) of subjects experiencing treatment-related adverse events by treatment, system organ class and preferred term.
Time frame: From first dose received up to 3.5 weeks + 30 days follow up after study completion for any unresolved adverse events.
Percentage of Subjects with treatment-related adverse events (AEs) after single-dose administration of Nicorette Strongmint Lozenge 4mg or NiQuitin Minimint Lozenge 4mg - By Worst-Case Severity.
Percentage (%) of subjects experiencing treatment-related adverse events by treatment, system organ class, preferred term and severity.
Time frame: From first dose received up to 3.5 weeks + 30 days follow up after study completion for any unresolved adverse events.
Percentage of Subjects with treatment-emergent serious adverse events (SAEs).
Percentage (%) of subjects experiencing treatment-emergent serious adverse events.
Time frame: From first dose received up to 3.5 weeks + 30 days follow up after study completion.
Plan to share: No
This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
McNeil AB